Eurotrol

GUDID 08718734960867

Eurotrol B.V.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

• Primary Device ID: 08718734960867
• NIH Device Record Key: 0ed77696-4312-4a56-b473-69c21234bf21
• Commercial Distribution Discontinuation: 2021-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Eurotrol
• Version Model Number: 179.001.010
• Company DUNS: 412925992
• Company Name: Eurotrol B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08718734960867 [Package]; Contains: 08718734960874; Package: [10 Units]; Discontinued: 2021-07-31; Not in Commercial Distribution
GS1	08718734960874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121468

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-09-16
• Device Publish Date: 2017-09-12

On-Brand Devices [Eurotrol]

• 08718734960928: Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level. It is a c
• 08718734960904: 179.003.010
• 08718734960881: 179.002.010
• 08718734960867: 179.001.010
• 08718734960539: Assayed Quality control solution
• 08718734960515: Assayed Quality control solution
• 08718734960492: Assayed Quality control solution